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Background: Studies have shown that pre/postnatal undernutrition leads to higher risk of non communicable diseases such as diabetes, hypertension and obesity in adulthood.

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Background Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD). Aims: Safety and efficacy assessment of a hypocaloric HP-diet supplemented with β-cryptoxanthin in NAFLD. Methods Ninety-two Iranian NAFLD outpatients were recruited for this 12-week, single-center, parallel-group, double-blind RCT and randomized into 4 arms (n = 23): HP-diet and β-cryptoxanthin (hypocaloric HP-diet + β-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), β-cryptoxanthin (standard hypocaloric diet + β-cryptoxanthin), and control (standard hypocaloric diet + placebo). Serum levels of liver enzymes and grade of hepatic steatosis were assessed at baseline and study endpoint as outcome measures. Results In the intention-to-treat population (N = 92), HP-diet and β-cryptoxanthin group experienced greater 12-week reductions in serum levels of liver enzymes than control group (mean difference for alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase: − 27.2, − 7.2, − 39.2, and − 16.3 IU/L, respectively; all p < 0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet and β-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, β-cryptoxanthin, and control groups, respectively; p < 0.001). Sixteen patients reported minor adverse events. Conclusion A hypocaloric HP-diet supplemented with β-cryptoxanthin safely and efficaciously improves NAFLD. Trial registration number This trial was registered at https://www.irct.ir as IRCT2017060210181N10.

Metabolic syndrome (MetS) is a chronic disease with inflammatory and hypercoagulable states. The current study aimed to compare the effects of flaxseed oil and sunflower oil consumption on the coagulation score and selected oxidative and inflammatory parameters in patients with MetS. In this randomized controlled clinical trial, 60 patients with MetS were allocated into 2 groups. One group received 25 mL/day flaxseed oil and the other group received 25 mL/day sunflower oil for 7 weeks. Maintenance diet including 15% protein, 55% carbohydrate, and 30% fat from daily total energy intake was designed for each participant. Serum levels of total antioxidant capacity (TAC) and interleukin 6 (IL-6), as well as coagulation score were measured before and after the intervention. Three 24-hour food records were taken during the study. Fifty-two of participants (27 in sunflower oil and 25 in flaxseed oil groups) completed the study. The baseline characteristics and dietary intakes were similar between patients. After 7 weeks, no significant difference was observed between the 2 groups regarding the serum TAC level and coagulation score (p > 0.05). However, serum IL-6 levels significantly decreased in the flaxseed oil group compared to the sunflower oil group (p = 0.017). No side effect was observed during the study due to the use of sunflower and flaxseed oils. We observed that consumption of flaxseed oil improved serum IL-6 levels but had no effect on oxidative stress and coagulation score in patients with MetS. Further studies are needed to confirm the veracity of our results.

The findings suggest that greater adherence to the DASH dietary pattern is associated with lower BP in healthy Iranian primary school children. However, future prospective studies of adequate methodological quality are warranted to confirm these findings.

BackgroundThere is controversy regarding whether increasing isolated soy protein (ISP) with or without flaxseed oil (FO), as functional foods, would lead to reduce muscle catabolism and cachexia in burn patients.MethodsOne hundred and eighty-eight patients were assessed for eligibility in this randomized controlled trial. Of these, seventy-three eligible patients (total burn surface area 20–50%) were randomly assigned to three groups, labeled as Control (wheat flour [WF] + corn oil [CO]), ISP + FO, and ISP + CO, to receive these nutrients for three weeks. Weight, body mass index (BMI), serum hepatic enzymes (alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase [ALP]), systemic inflammatory response syndrome (SIRS), 24-h urinary urea nitrogen excretion (UUN), serum creatinine, 24-h urinary creatinine (UUC) excretion, fasting blood sugar (FBS), triglyceride (TG), and cholesterol were measured.ResultsUsing analysis of covariance models in the intention-to-treat population (n = 73), we found that at three weeks, patients in the ISP groups had lost significantly less in weight and BMI compared to those in the control group (all P < 0.01). Nitrogen retention and serum creatinine (primary outcomes) increased significantly in the ISP groups compared with the control group. Even after controlling for potential covariates in ANCOVA models, changes in these indices were still statistically significant (P = 0.008 and P = 0.005 for nitrogen balance and serum creatinine, respectively). However, no such significant differences were found between the ISP groups. On the other hand, 24-h UUN, and UUC excretion, serum hepatic enzymes, FBS, TG, and cholesterol were not significant between the groups (P > 0.05).ConclusionISP and FO compared to WF and CO reduced muscle catabolism and increased body weight in burn patients.Trial registrationIranian Registry of Clinical Trials, IRCT2014051817740N1. Registered on 27 June 2014.

AbstractsBackgroundExcessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation through an increase in hepatic energy expenditure. Furthermore, the majority of randomized controlled trials (RCT) in humans have failed to show whether carotenoids can be used to prevent and treat non-alcoholic fatty liver disease (NAFLD). However, it is notable and contradictory that NAFLD is rapidly escalating in Iran and other countries with lower intakes of fruit and vegetables (as sources of β-cryptoxanthin [β-CX] and carbohydrates) and higher intake of carbohydrates (as an agent of NAFLD); and the effects of β-CX and a high protein diet (HPD) on NAFLD need to be investigated further.Methods/designThis study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for 12 weeks to receive daily β-CX 6 mg supplementation combined with a HPD on levels of metabolic factors, β-CX, glycemic and lipid profiles, inflammatory factors, adipocytokines, and body composition. Ninety-two eligible patients, aged 18–60 years, of both genders, who are obese and overweight (body mass index [BMI] 25–40 kg/m2) will be randomly assigned to four groups as follow: HPD + placebo; normal protein diet + β-CX (NPD + β-CX); HPD + β-CX; and NPD + placebo (control group). Two populations will be analyzed in this work. The intention-to-treat (ITT) population includes all patients who will be randomized, while the per-protocol (PP) population includes all individuals who complete the 12- week intervention (i.e. study completers).DiscussionOur findings from this trial will contribute to the knowledge of the relationship between β-CX supplementation and a HPD on NAFLD patients and determination of optimal macronutrient ratios without energy restriction.Trial registrationIran clinical trials registry, IRCT2017060210181N10. Registered on 20 June 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3014-8) contains supplementary material, which is available to authorized users.